Evaluating the interaction of Ritonavir and Itraconazole with SHR-A1811 in advanced breast cancer patients

A Multicenter, Open-label, Fixed-sequence Study to Evaluate Drug-drug Interaction of Ritonavir and Itraconazole on the Pharmacokinetics of SHR-A1811 in Subjects With HER2-expressing Advanced Breast Cancer

This study is testing how well a new drug called SHR-A1811 works on its own and with other medications in people with advanced breast cancer to see how they interact and affect treatment.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. (Industry-sponsored)
• Drugs / interventions: trastuzumab, pertuzumab, radiation
• Locations: 2 sites (Guangzhou, Guangdong and 1 other locations)
• Trial ID: NCT06710990 on ClinicalTrials.gov

What this trial studies

This study investigates the pharmacokinetics and safety of SHR-A1811, both as a standalone treatment and in combination with Ritonavir or Itraconazole, in patients with HER2-expressing advanced breast cancer. It aims to understand how these drugs interact and affect the absorption and metabolism of SHR-A1811. The study will enroll participants who meet specific health criteria and will monitor their responses to the treatment regimen over time.

Who should consider this trial

Good fit: Ideal candidates for this study are patients with HER2-expressing advanced breast cancer who have an ECOG score of 0 or 1 and meet specific organ function criteria.

Not a fit: Patients with known active central nervous system metastases that have not been treated may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment options for patients with HER2-expressing advanced breast cancer.

How similar studies have performed: While this approach is focused on a specific drug interaction, similar studies have shown promise in optimizing treatment regimens for cancer therapies.

Eligibility criteria

Inclusion Criteria:

1. ECOG score of 0 or 1;
2. Expected survival of not less than 3 months;
3. Important organ functions meet the following criteria:

   * Absolute neutrophil count (ANC) ≥1.5×109/L (1,500/mm3);
   * Platelet count (PLT) ≥100×109/L (100,000/mm3);
   * Hemoglobin (Hgb) ≥9.0 g/dL (90g/L);
   * Albumin level ≥3.0 g/dL;
   * Total serum bilirubin ≤1.5× the upper limit of normal (ULN);
   * Prothrombin time and activated partial thromboplastin time (aPTT) ≤1.5×ULN;
   * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN (for patients with liver metastasis, ALT and AST ≤5×ULN);
   * Serum creatinine ≤1.5×ULN or creatinine clearance ≥60 mL/min;
   * QTcF ≤470 msec;
   * Left ventricular ejection fraction (LVEF) ≥50%.

Exclusion Criteria:

1. Known active central nervous system metastases that have not been treated with surgery or radiation, except those that have been stable for at least 1 month after treatment and have discontinued corticosteroids for \>2 weeks;
2. Having cardiac diseases, such as severe/unstable angina, symptomatic congestive heart failure (NYHA II-IV), clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention, myocardial infarction within 6 months before the first administration, etc.
3. Known severe allergic history to any component of the SHR-A1811 product (ADC, total antibody, unconjugated toxin SHR169265 or its excipients), or hypersensitivity to humanized monoclonal antibody products (such as trastuzumab, pertuzumab, etc.);
4. Having contraindications to ritonavir or itraconazole use;
5. Having one or more factors that affect oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction, partial or total gastrectomy, etc.), or having active gastrointestinal diseases or other diseases that may significantly affect drug absorption, distribution, metabolism, or excretion.

Where this trial is running

Guangzhou, Guangdong and 1 other locations

• Sun Yat-sen Memorial Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)
• Hunan Cancer Hospital — Changsha, Hunan, China (Recruiting)

Study contacts

• Study coordinator: Meijing Yu

Conditions Advanced Breast Cancer